The U.S. FDA accepted Telix Pharmaceuticals’ resubmitted NDA for TLX101-Px (Pixclara), a radiolabeled imaging agent for characterizing progressive or recurrent glioma in both adult and pediatric patients. The agency assigned a Sept. 11, 2026 PDUFA date, moving the program back into an active regulatory review lane. Pixclara is intended to support clinical decision-making by visualizing tumor features associated with glioma progression or recurrence. FDA acceptance after resubmission indicates the company met the threshold for filing completeness and review readiness. For Telix and competitors in molecular imaging, the milestone matters because dosing, labeling language, and review timelines can affect adoption in oncology workflows that increasingly rely on standardized imaging agents. The assigned PDUFA date gives the market a concrete calendar catalyst for potential approval outcomes.